Prebiotic Microbiome Modulator for Reduced GI Side Effects of Metformin in Youth with Type 2 Diabetes
This phase 2 study aims to evaluate how well a prebiotic microbiome modulator reduces gastrointestinal side effects, such as stool consistency, urgency to evacuate, bloating, and flatulence, in young individuals with Type 2 diabetes who are taking Metformin.
Biomebliss
+ Metformin
+ Placebo
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: March 10, 2020
Actual date on which the first participant was enrolled.This study focuses on Type 2 Diabetes in youth and young adults, specifically looking at how Metformin, a common anti-diabetes medication, impacts them. Metformin, while effective, often causes gastrointestinal (GI) symptoms such as bloating, discomfort, and diarrhea. The study aims to find ways to reduce these side effects, as there are limited alternative treatments for youth with Type 2 Diabetes. The research suggests that changes in the gut or the microbiome due to Metformin may be linked to both its benefits and adverse effects. The study will explore if prebiotic fibers, non-digestible food ingredients that promote beneficial bacteria and stool metabolites, can improve Metformin tolerability and alter the stool metabolite profile in youth with Type 2 Diabetes. The 9-week study is divided into two phases. Phase 1 is a 5-week randomized double-blind cross-over trial where participants will receive either Metformin with a prebiotic or Metformin with a placebo, while following a standardized diet. Phase 2 is an open-label 4-week intervention where all participants will receive Metformin and the prebiotic. The study's primary outcome is to measure a composite GI tolerability score based on four categories: stool consistency, urgency to evacuate, bloating sensation, and flatulence. This score will be calculated using a principal components analysis, with a higher score indicating lower side effects.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 25 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* INCLUSION CRITERIA: 1. Age 10-25 years 2. Pubertal or post-pubertal: Girls - Tanner stage IV-V breast; Boys - Testicular volume \>10cc 3. Diagnosis of type 2 diabetes by American Diabetes Association (ADA) guidelines \[36\] or with established diagnosis previously treated with metformin. 4. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2)) documented in NIH CRIS chart or via outside laboratory assessment within the last 10 years. 5. Hemoglobin A1C \<8% at study initiation EXCLUSION CRITERIA: 1. Pregnancy or breastfeeding 2. Allergy to study medications 3. Allergy or self-reported intolerance to blueberry, pomegranate, or oats, soy, gluten or dairy products. 4. Chronic insulin therapy or insulin use within the last 3 months 5. Treatment with other medications which are known to affect the parameters under study, including antibiotics within the last month, immunosuppressants, proton-pump inhibitors, supraphysiologic systemic steroids, probiotic or prebiotic supplements 6. Heavy yogurt consumption (2 or more servings of \>=6 oz per day) 7. Chronic GI disease, gastric bypass surgery, cancer diagnosis or autoimmune disease 8. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose \>= 200mg/dL), and/or liver enzymes \> three times the upper limit of normal. 9. Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data. 10. Body weight \>= 450lbs 11. Body weight \<=58kg 12. Hemoglobin concentration \<10g/dL
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps